The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain

Chang Gung Medical Foundation

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Procedure: Hotpacking; Procedure: Transcutaneous electrical nerve stimulation (TENS); Dietary Supplement: Fish oil; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02774109

FishOilonCNLBP201604

Details and patient eligibility

About

Objectives:

To investigate the efficacy of omega-3 polyunsaturated fatty acids (PUFA) on patients with chronic nonspecific low back pain (NLBP).

Methods and Materials:

Twenty-nine patients with chronic NLBP were randomly divided into experimental and control groups. For 8 weeks, participants in the experimental group received omega-3 PUFA at 3000 mg/day plus physical therapy, while those in the control group received placebo plus physical therapy. The visual analog pain scale, pressure algometer, Biering-Sorenson test, Roland-Morris Low Back Pain and Disability Questionnaire (RMQ), and occupational burnout inventory (OBI) were used in assessments at baseline (T0) and after 4 (T1) and 8 weeks (T2). Serum erythrocyte sedimentation rate (ESR) and hypersensitive C-reactive protein (hs-CRP) were checked at baseline and T2.

Full description

Low back pain is a common symptom in modern society. However, nearly 85% of those who seek medical care for low back pain have no specific history and no specific finding in image study, and therefore do not receive a specific diagnosis. This type of low back pain is termed "nonspecific low back pain." Fish oil contains omega-3 polyunsaturated fatty acid, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA can reduce the synthesis of prostaglandin E2. They are also the precursors of the E-resolvin and D-resolvin that suppress inflammatory cytokine production and act to resolve inflammation. Several previous studies showed that fish oil has the effect of anti-inflammation and pain reduction without side effect that affecting stomach and renal function. Therefore, fish oil is considered a new type of NSAID, and many studies are investigating its effect of anti-inflammation and pain reduction on different diseases. The purpose of this study is to investigate the effects of fish oil on patients with chronic nonspecific low back pain.

Enrollment: 29 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female aged 20-50
• Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS

Exclusion criteria

• History of major trauma or surgery at back
• Obvious spinal pathology on plain film (e.g. scoliosis, spondylosis, spondylolisthesis)
• Not suitable for taking fish oil or receiving physical modality treatment
• Having other inflammatory disease (e.g. rheumatic arthritis, endometriosis, ankylosing spondylitis, infection)
• Pregnancy
• Regularly taking fish oil or fatty fish more than 2 times per week
• Having coagulopathy or currently taking anti-coagulation agent
• Receiving oral or topical NSAID in the past one week
• Taking oral corticosteroid in the past 6 weeks
• Receiving local injection of corticosteroid or prolotherapy in the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Participants in the experimental group will take fish oil (five 1000mg fish oil soft capsules per day, each capsule containing 350mg EPA and 250mg DHA) and receive physical modality treatment (hotpacking 15min and transcutaneous electrical nerve stimulation (TENS) 15min, three times a week) for 8 weeks

Treatment:

Procedure: Transcutaneous electrical nerve stimulation (TENS)

Dietary Supplement: Fish oil

Procedure: Hotpacking

Control group

Placebo Comparator group

Description:

Participants in the control group will take placebo (five 1000mg sunflower oil soft capsules per day) and receive physical modality treatment (hotpacking 15min and transcutaneous electrical nerve stimulation (TENS) 15min, three times a week) for 8 weeks

Treatment:

Procedure: Transcutaneous electrical nerve stimulation (TENS)

Dietary Supplement: Placebo

Procedure: Hotpacking